FDA-Device2016-08-24Class II
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Ab Sciex
Hazard
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Sold states
Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
Affected count
124 units
Manufactured in
500 Old Connecticut Path, N/A, Framingham, MA, United States
Products
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2526-2016Don't want to check this manually?
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